Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Kit Includes: (T007B-L) B-Series FlipTop™ Cassette - LiftOut Rack 7 (R064) Columbia 13-14 (R166) 5 Explorer (R245) Cone Socket Mirror Handle (T042) Meriam Tweezers (T050) #5 Mirror (15/16") (T816) Ligature Scissors (13cm) FDA UDI
- Model / Reference
- R928 PDT Suture Removal Kit FDA UDI
- Description
- Kit Includes: (T007B-L) B-Series FlipTop™ Cassette - LiftOut Rack 7 (R064) Columbia 13-14 (R166) 5 Explorer (R245) Cone Socket Mirror Handle (T042) Meriam Tweezers (T050) #5 Mirror (15/16") (T816) Ligature Scissors (13cm) FDA UDI
Identifiers
- Catalog Number
- R928 FDA UDI
- Primary DI / UDI-DI
- 00813677024930 FDA UDI
- FDA Product Code
- FSM FDA UDIEMS FDA UDIEKB FDA UDIEJB FDA UDIEJY FDA UDIEAX FDA UDIEGN FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Instrument tray, reusableSurgical soft-tissue manipulation forceps, tweezers-like, reusablePeriodontal curetteDental surgical probe, reusable
PDT, Inc. by PDT, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture scissors.
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- Sklar® — Sklar Corporation · Class I
- Quinelato — Schobell Industrial Ltda · Class I
- Rocket — Rocket Medical Plc
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- STOMA® — Storz am Mark GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PDT, Inc.
Sources (1)
- FDA UDI 48bdc9c0-0a2f-41ea-a75e-e90df77775bd 34 fields · synced Jun 9, 2026